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Schedule and Program for the FDA-ASH Sickle Cell Disease (SCD) Clinical Endpoints Workshop

The FDA-ASH SCD Clinical Endpoints Workshop took place over the course of two days; below is an overview of each day. 

  • 7:00 a.m.  Registration and Breakfast Available 
    8:00 a.m. Welcome and Introductions
    Alexis A. Thompson, MD, MPH
    ASH President
    Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University
    8:15 a.m. Workshop Objectives and Regulatory Background
    Ann Farrell, MD
    Workshop Co-Chair
    U.S. Food and Drug Administration
    8:30 a.m. Overview of SCD Endpoints: Then, Now, and Beyond
    Julie Panepinto, MD, MSPH
    Workshop Co-Chair
    Medical College of Wisconsin
    9:00 a.m. Panel Session: Patient Reported Outcomes (PROs)
    Patrick Carroll, MD
    Panel Chair
    Johns Hopkins University
    10:30 a.m. Coffee Break
    10:45 a.m. Panel Session: Pain (non-PROs)
    Deepika S. Darbari, MD
    Panel Chair
    Children’s National Medical Center
    12:15 p.m. Lunch
    1:15 p.m. Panel Session: Brain
    Allison King, MD, MPH
    Panel Chair
    Washington University in St. Louis
    2:45 p.m. Coffee Break
    3:00 p.m. Panel Session: End Organ Considerations
    Panel Chair
    Jeffrey Lebensburger, DO
    University of Alabama at Birmingham
    4:30 p.m. Workshop Day 1 Wrap-Up
    5:00 p.m. Adjournment
  • 7:00 a.m.  Registration and Breakfast Available
    7:30 a.m. Panel Session: Biomarkers
    Ankit Desai, MD
    Panel Chair
    Indiana University
    9:00 a.m. Coffee Break
    9:15 a.m. Panel Session: Endpoints for How to Measure Cure
    Mark Walters, MD
    Panel Chair
    Children’s Hospital of Oakland
    10:45 a.m. Coffee Break
    11:00 a.m. Panel Session: Considerations of Endpoints for Low Resource Settings
    Adetola A. Kassim, MD, MS
    Panel Chair
    Vanderbilt University
    12:15 p.m. Lunch
    1:00 p.m. Patient Panel
    1:50 p.m. Industry Panel
    2:40 p.m. Research Organization Panel
    3:30 p.m. Workshop Summary and Closing Remarks
    4:00 p.m. Adjournment